Kornimate/medical-research-clean huggingface dataset:
investigation of intravenous tranexamic acid with anatomic and reverse total shoulder arthroplasty

Conditions: Blood Loss; Anatomic Total Shoulder Arthroplasty; Reverse Total Shoulder Arthroplasty; Transfusion; Tranexamic Acid

Summary: to compare intravenous tranexamic acid (txa) versus normal saline placebo to determine whether or not txa administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (tsa) surgeries.

anatomic and reverse total shoulder arthroplasty (tsa) is associated with the risk of moderate to significant blood loss that can lead to transfusions. average estimated blood loss has been reported in the range of 354 to 361 ml intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. tranexamic acid (txa) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. txa can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of txa compared to placebo. moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with txa administration for hip and knee arthroplasty. despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of txa to reduce blood loss and transfusion rate following tsa. purpose of the study is to compare intravenous tranexamic acid (txa) versus normal saline placebo to determine whether or not txa administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (tsa) surgeries. with the hypothesis that intravenous txa will reduce blood loss following tsa.

Eligibility criteria:
inclusion criteria: * any patient scheduled for a primary anatomic or reverse tsa exclusion criteria: * allergy to txa * acquired disturbances of color vision * pre-op use of anticoagulant therapy within five days before surgery * history of arterial or venous thromboembolic disease; such as dvt, pe, cva, tia * pregnancy or breastfeeding * recent mi (within 6 months of surgery) or any placement of stent regardless of time since placement * renal impairment * refusal of blood products * any patient undergoing a revision tsa * patients who decline to participate
pexiganan versus placebo control for the treatment of mild infections of diabetic foot ulcers

Conditions: Diabetic Foot Infection

Summary: the purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.


Eligibility criteria:
inclusion criteria: 1. diabetes mellitus. 2. male or female at least 18 years old. 3. subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent. 4. subject is to be treated on an outpatient basis. 5. full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement. 6. localized mild infection of the ulcer. 7. the diagnosis of mild infection must be confirmed immediately following debridement at baseline. 8. subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot. exclusion criteria: 1. idsa-defined moderate infection. 2. idsa-defined severe infection. 3. infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware. 4. \> 1 infected foot ulcer. 5. subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment. 6. subject has received a systemic antibiotic within 48 hours prior to screening. 7. concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer. 8. bone or joint involvement is suspected based on clinical examination or plain x-ray. 9. clinically significant peripheral arterial disease requiring vascular intervention. 10. subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.

Keywords: diabetic foot ulcer infection
evaluation of compression therapy in patients with mild to moderate pad or diabetes mellitus

Conditions: Peripheral Arterial Disease; Diabetes Mellitus; Leg Edema

Summary: aim of this prospective clinical study is the evaluation of the effect of compression therapy on the microcirculation in patients with leg edema and mild to moderate pad or diabetes mellitus.

aim of this prospective clinical study is the evaluation of the effect of compression therapy on the microcirculation in patients with leg edema and mild to moderate pad or diabetes mellitus. the microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (o2c device, parameters so2, flow, rhb). by this, it is possible to detect the influence of the compression therapy on the skin microcirculation. therefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate pad and diabetics. all patients are recieveing compression therapy (compression stockings class i for three hours, after a short break compression stockings class ii for 3 hours) under perfusion assessment control (o2c device).

Eligibility criteria:
inclusion criteria: study-arm pad: * leg edema * symptomatic pad (fontaine stage ii) * no palpable foot pulses * abi \ 0.6, absolute ankle pressure \> 60mmhg study-arm diabetes: * leg edema * diabetes mellitus typ 2 (history of longer than 2 years) * palpable foot pulses * pallaesthesie \>6 * wagner score 0 exclusion criteria: study-arm pad: * critical limb ischemia * abi \< 0.6 * simoultaneous diabetes mellitus study-arm diabetes: * wagner score \>0 * pallasthesie \<6

Keywords: compression therapy microcirculation diabetes mellitus peripheral arterial disease
testing a positive psychology-based intervention for couples coping with stroke

Conditions: Stroke; Depression; Depressive Symptoms; Post-stroke Depression

Summary: this study aims to pilot test an 8-week, self-administered dyadic (couples-based) positive psychology intervention for couples coping with stroke using a randomized, waitlist control design. mood and well-being will be assessed pre- and post-intervention, and at 3-month follow-up. it is expected that both partners will demonstrate improvement in mood and well-being.

stroke survivors and spousal caregivers face significant challenges, yet interventions to support couples after stroke are largely lacking. depressive symptoms post-stroke occur in 30-50% of survivors and partner caregivers, and have significant consequences on function and quality of life. further, mood and psychosocial well-being are reciprocal in couples, meaning if one partner is depressed, the other is more likely to be depressed. sustaining well-being in both partners is important for continued engagement in rehabilitation and re-integration into the community, yet existing interventions are aimed at the individual rather than the couple. this study will address this gap by testing an innovative dyadic (couples-based) intervention using a new approach based on positive psychology that focuses on the strengths in the relationship in order to foster resilience in the couple. using a randomized waitlist control design, this pilot study aims to determine whether an 8-week dyadic positive psychology-based intervention (ppi) can improve mood and subjective well-being as assessed by established outcome measures in 24 couples coping with stroke. the intervention consists of self-administered ppi activities, such as expressing gratitude and practicing acts of kindness, which participants complete individually and as a couple. two potential pathways will be explored for the ppi: (a) enhanced quality of interactions as couples deal with daily life demands and (b) improvements in mood that are "contagious" among couples. if found effective, couples with greater well-being may be better emotionally equipped to cope with the sequelae of stroke by reducing stress and depressive symptoms, and increasing participation in meaningful activities and quality of life.

Eligibility criteria:
inclusion criteria: * couples consist of one partner who had an ischemic or hemorrhagic stroke \>3 months ago and a cohabiting partner (\> 1 year) who self-identifies as the caregiver and is willing to enroll in the study; * either one or both partner(s) report depressive symptoms as assessed by the promis-d (no formal diagnosis is required). exclusion criteria: * the caregiver has had a stroke or other major neurological condition; * either partner is unable to understand the printed english instructions; * either partner scores \<19 (the established cut-off for mild cognitive impairment) on the montreal cognitive assessment (moca), a validated screening instrument for cognitive performance.

Keywords: couples positive psychology behavioral intervention stroke depression wellbeing caregiver
predicted level of general anaesthesia in hip fracture surgery

Conditions: Hip Fracture Surgery

Summary: the purpose of this study is to evaluate if prediction of general anaesthesia level by the smartpilot® view device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.


Eligibility criteria:
inclusion criteria: * patient undergoing hip fracture surgery under general anaesthesia * age ≥ 18 years old * asa classification 1, 2 or 3 exclusion criteria: * patient not insured by a social security scheme * adult patient under tutorship or curatorship * age over 18 years old or under 90 years old * weight under 40 or over 140 kilos and/or height under 150 or over 200 cm * body mass index \> 35 * contraindication to one or more anaesthetics used in the study * pregnancy or breastfeeding * unweaned alcoholism * asa classification 4 or 5 * patient undergoing hip fracture surgery under spinal anaesthesia

Keywords: smartpilot view hip fracture surgery depth of anaesthesia intraoperative hypotension quality of anaesthesia
axillary reverse mapping for breast carcinomas

Conditions: Axillary Dissection

Summary: distinct arm from breast axillary dissection (ad), or axillary reverse mapping (arm), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. this represents a new surgical technique that is the focus of recent surgical interest.

distinct arm from breast axillary dissection (ad), or axillary reverse mapping (arm), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. this represents a new surgical technique that is the focus of recent surgical interest. the assumption is that the sentinel node (sn) of the upper limb is different from the sn of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. during the arm procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.the ultimate goal for arm procedure is to reduce the rate of lymphedema in n+ patients requiring an ad.

Eligibility criteria:
inclusion criteria: * indication for formal axillary dissection (ad) * n0 patient with a large tumor: t3 * n1 patient * n2 patient with axillary imaging showing limited node involvement(1-4n+). * secondary ad after a positive sentinel node ( pn1, pn1(mi)) * ad after préopérative chemotherapy in a patient initially n+. * age between 18 and 70 * signature of the consent form. * patients beneficiary of the social security exclusion criteria: * n0 patient with an indication of sentinel node biopsy * n2 patient with axillary imaging showing suspected node involvement \>4n+. * n3 patient * age over 70 * pregnancy * blue dye allergy * mentally deficient patient

Keywords: axillary dissection
clinical value of left atrial appendage flow for prediction of successful catheter ablation for persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation; Catheter Ablation

Summary: the purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (tee), predicts the outcome after catheter ablation of persistent atrial fibrillation( paf).

40 paf patients underwent 3d mapping and ablation. a stepwise approach including circumferential pulmonary vein (pv) isolation, continuous complex-fractionated electrogram (cfe) ablation and linear ablation was performed by the same operator. the procedural end point was termination of persistent af by catheter ablation, either by conversion directly to sinus rhythm or to atrial tachycardia. left atrial appendage (laa) peak flow velocities were measured with transesophageal echography and averaged within each rr interval of 10 consecutive cardiac cycles.

Eligibility criteria:
inclusion criteria: * first-time radiofrequency catheter ablation for paf. paf was defined as continuous af lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion. * informed consent exclusion criteria: * severe valvular disease requiring surgery * valvular prosthesis * known severe coronary artery disease * atrial and/or ventricular thrombosis * new york heart association functional class iii to iv * cerebrovascular disease * pulmonary embolism * latent or manifest hyperthyroidism

Keywords: atrial fibrillation ablation catheter left atrial appendage peak emptying velocity tool for predicting successful catheter ablation
treatment of infertility by collagen scaffold loaded with autologous bone marrow stem cells

Conditions: Infertility; Intrauterine Adhesions; Endometrial Dysplasia

Summary: study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with autologous bone marrow stem cells, and to provide clinical evidence for the treatment of uterine infertility

infertility is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. there is no effective treatment to the infertility caused by severe intrauterine adhesions or endometrial dysplasia which affects embryos implantation. the existing drugs, physical or surgical treatments had no significant effects to severe intrauterine adhesions.collagen is the main component of the extracellular matrix with good biocompatibility, and it has been approved for the reparation of skin and oral mucosa by state food and drug administration. bone marrow stem cells have been used in the clinical treatment of blood diseases, and achieved good results. in this study, collagen scaffold and autologous bone marrow stem cells are combined, and they showed good biological safety

Eligibility criteria:
inclusion criteria: * infertility caused by serious intrauterine adhesions or endometrial dysplasia * hysteroscopy examination confirmed intrauterine adhesions or endometrial dysplasia * monitoring of endometrial cycle * sign a consent form * follow the test plan and follow-up process exclusion criteria: * abnormal chromosome karyotype * congenital uterine malformations * severe endometriosis * severe adenomyosis * contraindications to pregnancy * contraindications to bone marrow collection * contraindications to hormone replacement therapy * medical history of pelvic tumors or receiving pelvic radiotherapy * unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period
methaload dose-finding study

Conditions: Opioid Use Disorder (OUD)

Summary: the goal of this proposal is to develop a "loading dose" approach to starting methadone to treat fentanyl opioid use disorder (oud). we aim to conduct an assessor-blinded dose-finding study of 24 participants with fentanyl oud recruited to a research unit for monitored methadone dosing. participants will be randomized to standard methadone initiation vs. one of three loading dose approaches. the primary goal is to identify the maximum tolerated methadone loading dose appropriate for future study.


Eligibility criteria:
inclusion criteria: 1. able to provide a dated written informed consent in english prior to the conduct of any study related procedures 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male, female, transgender, or non-binary aged 18 or older 4. in good general health as evidenced by medical history. 5. fentanyl positive urine drug test 6. ability to take oral medication and be willing to adhere to the dosage regimen 7. for females of reproductive potential: negative urine pregnancy test on screening and on admission 8. dsm-5 criteria for opioid use disorder, moderate to severe 9. interest in starting methadone treatment for opioid use disorder at merakey parkside (our partner outpatient treatment program where we will send patients on discharge from the study) exclusion criteria: 1. previously documented hypersensitivity or allergy to methadone 2. prolonged qtc (=450ms in men, =460ms in women), previously documented long qt syndrome, history of qt prolongation, or history of ventricular arrhythmia (e.g., torsades de pointes) 3. pregnancy or lactation 4. dsm-5 criteria for benzodiazepine or alcohol use disorder 5. urine drug testing at screening positive for buprenorphine and/or methadone 6. ast and/or alt 3x upper limit of normal or total bilirubin or equal to 1.5x upper limit of normal 7. egfr less than or equal to 60 ml/min 8. chronic hypotension (\<90/50 mmhg) or episodic symptomatic hypotension (history of active or recurrent orthostatic hypotension or syncope). 9. significant chronic pulmonary disease: copd with modified mrc dyspnea scale \>=3 ("i stop for breath after walking about one city block") or requiring oxygen (chronically or at bedtime) 10. active, chronic use of the cyp3a4-inducers or -inhibitors rifampin, phenytoin, st john's wort, phenobarbital, carbamazepine, voriconazole, efavirenz, nelfinavir, nevirapine, ritonavir, and lopinavir+ritonavir, abacavir, or amprenavir 11. significant medical symptoms, psychiatric symptoms, or dementia that, in the opinion of the investigators, would preclude compliance with the protocol, cooperation in the study, obtaining informed consent, or ability to safely participant in the study 12. pending legal action that could prohibit participation and/or compliance in study procedures

Keywords: methadone fentanyl opioid use disorder opioid addiction opiate addiction oud
metagenomic analysis of the link between periodontitis and smoking: case-control study

Conditions: Condition, Chronic Periodontitis

Summary: periodontitis is a widely prevalent disease worldwide that has serious public health consequences. its prognosis includes tooth loss and edentulism, a condition that negatively affects chewing causing functional disability; and esthetics causing social impairment. consequently, periodontitis may end up causing marked impairment of the quality of life of the affected patients, impairment of general health and increasing the dental care costs significantly. dysbiotic changes in the oral microbiome arise after some microbial species are enriched by primary products resulting from tissue breakdown due to gingivitis. it then triggers the host cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical migration of the junctional epithelium and apical spread of bacterial biofilm. however, the dysbiotic changes may be more likely to occur in some patients rather than others due to certain risk factors including smoking and immuneinflammatory responses. thus, the severity of periodontal disease in these patients would be higher. tobacco smoking is no longer considered to be a habit, but a dependence to nicotine and a chronic relapsing medical disorder. among its detrimental effects on general health, tobacco smoking increases the risk of periodontitis by 2 to 5 folds. this takes place by increasing the dysbiotic changes in the oral microbiome and so, increasing the severity and extent of the periodontal disease at a younger age. therefore, smoking has been considered as a modifying factor of periodontitis that should be considered upon periodontitis case grading definition. therefore, this research aims to identify the difference in dysbiosis between the three categories of periodontitis, trying to understand the cause of the resistance of each category to treatment compared to the milder category.


Eligibility criteria:
inclusion criteria: * patients 18 years or older. * patients with periodontitis. * probing pocket depth ≥ 4 mm. * teeth with cal≥ 3 mm at ≥2 non-adjacent teeth. * clinical indication and/or patient request for treatment of the periodontal condition. exclusion criteria: * patients with any systemic diseases. * pregnant females. * patients who took any antibiotic in the past month. * handicapped and mentally retarded patients. * patients undergoing radiotherapy.